Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010693883

FEI Number

3010693883

Entity Name

HUREV CO., LTD.

City/State/Country

Gangwon-do, KR

Establishment Address

107-3 Donghwagongdan-ro Munmak-eup, Wonju-si, Gangwon-do KR 26365, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

HUREV Co., Ltd. (Owner Number: 10046045)

Owner / Operator Contact Address

107-3 Donghwagongdan-ro, Munmak-eup, Wonju-si, KR-42 26365, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Baxter Starling Sensors & Cheetah Sensors; HeartRode ECG Electrode; HeartRode Pre-Wired ECG Electrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2014-01-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

HUREV Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010693883. Last updated year: 2026. Please use registration number 3010693883 when referencing this establishment in official correspondence.